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Table 2 National Cancer Institute Common Toxicity Criteria for Adverse Events in study population (n = 15)

From: Phase I clinical trial of a novel autologous modified-DC vaccine in patients with resected NSCLC

A

Adverse Event

Total, n (%)

N = 15

 

Any Grade

Grade 1–2

Grade 3–4

Pyrexia

6 (40%)

6 (40%)

0

Fatigue

5 (33.33%)

5 (33.33%)

0

Palpitate

1 (6.67%)

1 (6.67%)

0

Headache

3 (20%)

3 (20%)

0

Chest pain

1 (6.67%)

1 (6.67%)

0

Chest Congestion

1 (6.67%)

1 (6.67%)

0

Abdominal pain

5 (33.33%)

5 (33.33%)

0

Abdominal distension

2 (13.33%)

2 (13.33%)

0

Nausea

3 (20%)

3 (20%)

0

Hypertension

1 (6.67%)

1 (6.67%)

0

Nasal congestion

1 (6.67%)

1 (6.67%)

0

CRP increased

7 (46.67%)

7 (46.67%)

0

Myalgia

6 (40%)

6 (40%)

0

Creatinine increased

2 (13.33%)

2 (13.33%)

0

Chills

1 (6.67%)

1 (6.67%)

0

B

Adverse Event

1 × 106, n (%)

1 × 107, n (%)

Maximum numbersof cultured cell, n (%)

 

N = 3

N = 3

N = 9

 

Any Grade

Grade 1–2

Grade 3–4

Any Grade

Grade 1–2

Grade 3–4

Any Grade

Grade 1–2

Grade 3–4

Pyrexia

0

0

0

1 (33.33%)

1 (33.33%)

0

5 (55.56%)

5 (55.56%)

0

Fatigue

1 (33.33%)

1 (33.33%)

0

1 (33.33%)

1 (33.33%)

0

3 (33.33%)

3 (33.33%)

0

Palpitate

1 (33.33%)

1 (33.33%)

0

0

0

0

0

0

0

Headache

1 (33.33%)

1 (33.33%)

0

1 (33.33%)

1 (33.33%)

0

1 (11.11%)

1 (11.11%)

0

Chest pain

1 (33.33%)

1 (33.33%)

0

0

0

0

0

0

0

Chest Congestion

1 (33.33%)

1 (33.33%)

0

0

0

0

0

0

0

Abdominal pain

3 (100%)

3 (100%)

0

0

0

0

2 (22.22%)

2 (22.22%)

0

Abdominal distension

0

0

0

1 (33.33%)

1 (33.33%)

0

1 (11.11%)

1 (11.11%)

0

Nausea

1 (33.33%)

1(33.33%)

0

0

0

0

2 (22.22%)

2 (22.22%)

0

Hypertension

0

0

0

1(33.33%)

1(33.33%)

0

0

0

0

Nasal congestion

1 (33.33%)

1 (33.33%)

0

0

0

0

0

0

0

CRP increased

2 (66.67%)

2 (66.67%)

0

1 (33.33%)

1 (33.33%)

0

4 (44.44%)

4 (44.44%)

0

Myalgia

1 (33.33%)

1 (33.33%)

0

1 (33.33%)

1 (33.33%)

0

4 (44.44%)

4 (44.44%)

0

Creatinine increased

0

0

0

2 (66.67%)

2 (66.67%)

0

0

0

0

Chills

1 (33.33%)

1 (33.33%)

0

0

0

0

0

0

0